Sunscreen TEAs Should Model Applications For Chronic-Use Cutaneous Drugs – FDA
This article was originally published in The Tan Sheet
Executive Summary
TEAs for UV filters should provide FDA with clinical safety data used to support approval of chronic-use cutaneous drugs and nonclinical testing should focus on potential long-term adverse effects, according to draft guidance required under the Sunscreen Innovation Act. FDA particularly is interested in comments about final formulation safety testing it anticipates requiring under specified monograph conditions.